Analyst - QC

Name of the Company – Zydus Healthcare Limited

Industry – Pharmaceuticals

Website of the company  - https://www.zyduslife.com/zyduslife/

Location –Sikkim Unit I & Unit II

Position -  Officer / Executive

Qualification – M.Sc. / B.Sc. in Chemistry, Microbiology & Biotechnology

Experience Required –  Between 1 to 4 Years Of Experience  

Role – QC Analyst

No’s of Vacancy - 5

Key Responsibilities

1. Perform analysis of Raw Materials (RM), Finished Products (FP), Stability Samples, Water Samples, and Microbiological Samples as per approved specifications and test methods.
2. Conduct testing using HPLC, GC, UV-Visible Spectrophotometer, FTIR, Dissolution, and other analytical instruments.
3. Perform microbiological testing including Environmental Monitoring, Water Testing, Bioburden, and Microbial Limit Testing.
4. Monitor stability studies and perform testing as per approved stability protocols and ICH guidelines.
5. Prepare and standardize reagents, volumetric solutions, culture media, and reference standards.
6. Review analytical and microbiological data and ensure compliance with established specifications.
7. Maintain laboratory records, logbooks, worksheets, analytical reports, and documentation as per GMP and GLP requirements.
8. Investigate OOS, OOT, laboratory incidents, and microbiological deviations.
9. Ensure compliance with GMP, GLP, Data Integrity, and Safety requirements.
10. Support method validation, method transfer, instrument qualification, and calibration activities.
11. Participate in internal audits, regulatory inspections, and compliance-related activities.
12. Coordinate with QA, Production, Engineering, and Regulatory Affairs for laboratory-related activities.
13. Ensure proper maintenance, calibration, and operation of laboratory instruments and equipment.

Required Skills

1. Hands-on experience with HPLC, GC, UV, FTIR, Dissolution, and other analytical instruments.
2. Knowledge of microbiological testing, Environmental Monitoring, and Water Analysis.
3. Understanding of GMP, GLP, Data Integrity, and laboratory compliance requirements.
4. Knowledge of pharmacopeial requirements including IP, USP, BP, and EP.
5. Familiarity with OOS, OOT, CAPA, Deviation, Change Control, and QMS processes.
6. Strong analytical, troubleshooting, documentation, and communication skills.
7. Proficiency in laboratory documentation and data review practices.

Preferred Experience

1. Experience in pharmaceutical Quality Control laboratories handling RM, FP, Stability, and Microbiology activities.
2. Exposure to regulatory audits and GMP-compliant laboratory operations.
3. Experience in analytical method validation, stability studies, and microbiological testing.
4. Knowledge of laboratory software, chromatography data systems, and electronic documentation practices.
5. Hands-on experience with regulated manufacturing environments and quality systems.

 Interested candidates may share their CV at Bishnu.M.Bhujel@zyduslife.com